Gimble J.M. Academia to Biotechnology: Career Changes at any Stage
Подождите немного. Документ загружается.
fling to the discovery process. How can you, as a leader, reconcile these
two apparently conflicting viewpoints?
Some argue that creativity and invention are qualities best displayed
by children at play. The most successful scientists are thought to retain this
child-like ability to play even as adults. Although you may remember your
childhood as a time of freedom, it helps to look back on that period with
an adult perspective. At age 4, you could do anything you wanted inside
the sandbox as long as no one else got hurt. Your mother did not mind if
you built castles, drove trucks, and generally made a mess. While you may
not have grown up to be an engineer, the experience did foster your sense
of imagination and creativity. Still, your mother did confine the dimensions
of your play with rules and physical boundaries. The structure of a labora-
tory or biotech company serves the same purpose. The key trick is to help
your team discover the place within your organization where they can still
play creatively in the sand. Even though the adult version of a sandbox is
more abstract, it is every bit as important as it was at age 4 to your scien-
tific staff. Find ways to protect this space, and use it to develop novel and
innovative discoveries.
REFERENCES
Fulghum, R. All I Really Need to Know I Learned in Kindergarten: Uncommon
Thoughts on Common Things. New York: Ballantine Books, 1993.
Kübler-Ross, E. On Death and Dying. New York: Macmillan, 1969.
Fostering Creativity 155
Ch23.qxd 28/7/04 1:28 PM Page 155
INDEX
157
A
Abbreviations, use in organizing
protocols, 96
Abstract
in patent applications, 36
submitting for off-site meetings, 109
Academia
academic freedom in, 124
communication skills essential to, 1
community service expectations in, 123
dress codes in, 89
expected milestones in, 120
grant expectations in, 121
implications of patents for, 37–38
infrastructure advantages of, 84
interpersonal relationships in, 90
patent record expectations in, 124–125
peer reviewing expectations in, 121–122
priorities in, 16
publication expectations in, 119–120
speaking engagement expectations in,
123–124
teaching expectations in, 122–123
transitioning to industry from, 135–136
vs. biotechnology, 84
Academic freedom, expectations in
academia and industry, 124
Accepted practice, for experimental
methods, 67–69
Accountability, role in good
laboratory/manufacturing practices, 46
Accounting departments, in biotech
subculture, 12–13
Accuracy of standards, in product design
process, 41
Adaptability, of job candidates, 101
Adult stem cell–based therapeutics,
40–44
Advanced Technology Projects grants,
commercialization plans in, 30
Adverse effects
documenting in Biologics License
Application, 43
documenting in product design
process, 41
Advertisements, recruiting personnel
via, 128
All I Really Need to Know I Learned in
Kindergarten, 148
American Cancer Society, 121
American Diabetes Association, 121
American Heart Association, 121
Animal care, in GLP inspections/
audits, 56
Index.qxd 7/29/04 4:49 PM Page 157
Animal model studies, 40
documenting unanticipated illness or
death in, 47
in land grant universities, 74
Animal studies, in GLP inspections/audits,
57–58
Animal Subjects Protection section, in
grant applications, 30–31
Antibodies, documenting, 50
Appendix, in experimental methods,
68–69
Assay procedures, 41
Association for Assessment and
Accreditation of Laboratory Animal
Care (AALAC), 30
Audience, considering for journal
manuscripts, 23
Audience identification
importance in public speaking, 3
in public speaking, 4
Audiovisual system malfunctions,
preparing for, 4
Authorization, role in good laboratory/
manufacturing practices, 46
Authorship
in biotech companies vs. academia,
87
issues in collaborations, 111
position, 120
Autonomy
and micromanagement tendencies,
147–148
for postdoctoral fellows, 78
in academia vs. biotech industry, 137
in biotech companies vs. academia, 87
B
Background information
in experimental protocols, 60
in grant applications, 28
in manuscript format, 22
in patent applications, 36
Background section, in grant applications,
26
Bar graphs, 23
Base salary, for postdoctoral fellows,
81–82
Basic research
culture of, 45
in public universities, 74
Basic science, 11
funding from National Science
Foundation (NSF), 75
Benefits, in academia vs. industry,
139, 140
Biologics
documenting, 50–51
federal approval process for, 39–44
Biologics License Application (BLA),
41, 42
in product design process, 42
major sections within, 43
role of standard operating procedures
in, 72
Biotechnology
communication skills essential to, 1
dress codes in, 89
priorities in, 16
role of experimental reports in, 63
subcultures of, 11–13
Biotechnology companies
business plans for commercialization,
30
exit strategies in, 91
factors in choosing, 83
interpersonal relationships in,
90–91
postdoctoral fellowships at, 74
researching stock value of, 86
salary and benefits in, 88–89, 91
selection criteria for, 85–89
title considerations, 88
vs. academia, 84
Bound notebooks, vs. loose-leaf
notebooks, 53
Budget preparation, in laboratory
administration, 104–105
Budget section, in grant applications,
26, 27
Business accounting, importance in grant
applications, 27
Business analysts, 16
Business development, in biotech
subculture, 12–13
Business plans, of biotechnology
companies, 30
C
Case Report Forms, in Biologics License
Application, 43
158 Index
Index.qxd 7/29/04 4:49 PM Page 158
Case Report Tabulations, in Biologics
License Application, 43
Casual dressing, effect on
communication, 2
Cell, 80
Cells, documenting, 51
Center for Biologics Evaluation &
Research (CBER), 40
Center for Devices & Radiological Health
(CDRH), 40
Center for Drug Evaluation & Research
(CDER), 40
Change, pace in biotech vs.
academia, 84
Checklists, standard operating procedures
as, 72
Chemical inventories, 94
Chemicals, documenting, 51
Chemistry, Manufacturing, and Controls
section, in Biologics License
Application, 43
Child care issues, 143–144
Claims section, in patent applications, 36
Clinical departments, as biotech
subculture, 12
Clinical indications, 41
Clinical Microbiology section, in Biologics
License Application, 43
Clinical products, and federal approval
process, 39–44
Clinical Section, in Biologics License
Application, 43
Clinical trials, 37
costs of, 42
in product design process, 41–42
protocols in product design process, 41
Clothing, influence on communication, 1
COBRA, 115
Code of Federal Regulations, 45
Collaborations, facilitating, 111–112
Collaborator support documents, in grant
applications, 26, 31
Commercialization plan, 39
in grant applications, 26, 30
Communication
effect of clothing on, 1–2
essential to science, 1
management techniques in, 9
nonverbal, 1–2
oral, 2–3
organizing, 6–9
structure of, 6–7
verbal, 2–6
written, 3–6
Communication skills, of job candidates,
101
Community service, expectations in
academia and industry, 123
Competencies and skills, in performance
review process, 101
Composition of matter, patenting, 35
“Comprising,” use in patent applications,
35
Conclusions section
in experimental reports, 64
in manuscript format, 22
Confidential disclosure agreement (CDA),
19, 38
Consensus building, 8, 9
“Consisting of,” use in patent applications,
35–36
Consultancy agreements, 38
Consultant support documents, in grant
applications, 26, 31
Consumables, documenting, 51
Contamination, documenting, 47
Contract research facilities, 41
in biotechnology companies, 84
in product design process, 41–42
Contracts, issues in laboratory closures,
114
Contraindications, 41
Controls, experimental, 23
Core facilities
cost of operating, 106
in mentor’s institution, 77
Corporate commitment, 85
Corporate culture
by investor–founder relationships, 90
in biotech companies, 89–90
in early-stage vs. mature biotech
companies, 91–92
Cost control, in laboratory environment,
105
Cost-of-living salary increases, 91
Creativity, ability to foster, 154–155
Cultural considerations, in biotechnology
employment, 83
Culture of secrecy, 87
Current Protocols series, 68–69
Curriculum vitae, in grant applications, 26,
27–28
Index 159
Index.qxd 7/29/04 4:49 PM Page 159
D
Data collection documents, 47–48
Data control procedures, 46
Data files, 48
Date of invention, establishing, 34
Decision trees
importance in grant applications, 18
in grant applications, 26
Defense Advanced Research Projects
Administration (DARPA), 29
Department of Commerce, regulations for
laboratory closures, 115
Department of Health and Human
Services Office for Human Research
Protections (OHRP), 30
Department of Transportation, regulations
for laboratory closures, 115
Dependent claims, 36
Description of Figures, in patent
applications, 36
Descriptive documents, 47
Detailed Description of the Invention, in
patent applications, 36
Development
as biotech subculture, 11–12
in product design process, 40–41
Deviations
in experimental reports, 64
recording, 47
Device
federal approval process for, 39–44
patenting, 35
Diagnostics, federal approval process for,
39–44
Direct costs, 105–106
Discovery research
document trail in, 71
experimental reports as records
of, 65
Discrimination, in hiring practices, 150
Discussion section
in experimental reports, 64
in manuscript format, 22
DNA analysis, 30
Document control systems
inventories of, 94
required by Securities and Exchange
Commission, 90
role in good laboratory/manufacturing
practices, 46
Document types, 48
Documentation, role in good
laboratory/manufacturing practices,
46
Documentation procedures, 47–49
Dress codes, in biotech vs. academia, 89
Drugs, federal approval process for, 39–44
E
Early-stage biotech companies, 91–92
Educational benefits, 107
Efficacy studies, 42
Electronic library access, 77
Employee termination, 133–134
Employment insecurity, in biotech vs.
academia, 84
Enthusiasm, importance to grant writing,
25
Equipment
documenting, 51
in experimental protocols, 60
in GLP inspections/audits, 55–56
in laboratory setup, 95
inventories of, 95
issues in laboratory closures, 116
Equipment calibration requirements, 49
Equipment certification, 41
Equipment expenditures, 121
Equipment identification, 49
Equipment liquidation, 116
Equipment maintenance, 103
Equipment manuals, centralized
repositories for, 95
Equipment safety features, 49
Equipment section, for experimental
methods, 68–69
Equipment utility requirements, 49
Equipment validation, 49
Establishment Certification section, in
Biologics License Application, 43
European Union, regulatory standards for
approval in, 39
Exceptional conditions, in experimental
reports, 64
Exclusivity, and patent applications, 35
Exercise, importance of, 145
Existing literature, review of, 22, 28
Exit strategies, in biotechnology
companies, 91–92
Expectations
academic freedom, 124
160 Index
Index.qxd 7/29/04 4:49 PM Page 160
community service, 123
for collaborations, 111
grants record, 121
honors and speaking engagements,
123–124
patent records, 124–125
peer reviewing, 121–122
professional publications, 119–120
teaching, 122–123
Experimental Animal Protection section,
in grant applications, 26
Experimental controls, 23
Experimental design section, in grant
applications, 26, 29
Experimental methods, 67
organization and contents of, 68–69
vs. standard operating procedures,
71–72
Experimental pitfalls, 29
Experimental protocols, 59–61
organization and content of, 59–61
Experimental reports, 63, 64–65
Experimental results, in experimental
reports, 64
Express shipment costs, 107
External audits, facilitated by standard
operating procedures, 71
F
Facilities, in GLP inspections/audits, 55
Family and friends issues, 144
Federal government
approval process, 39–44
grants from, 17
Federal regulations, role in good
laboratory/manufacturing practices,
53–54
Fee-for-service laboratories, 138
Filing fees, in patent applications, 35,
36–37
Financial resources
allocation for manuscripts, 23
as influence on corporate culture, 89
in biotech companies, 87–88
in laboratory administration,
104–107
in patent applications, 35
of mentor’s laboratory, 77
First to file, 34
First to invent, 33
Fitness centers, 145
Flow charts, in grant applications, 26
Focus, of grants, 17
Forbidden information, 98
in interviewing job candidates, 129
Freezer contents, inventories of, 94
Fringe benefits
accounting for in grant applications, 27
for postdoctoral fellows, 82
in laboratory environments, 107
Fulgham, Robert, 148
Funding issues
at public vs. private universities, 75
control in biotechnology vs. academia, 84
in choice of postdoctoral mentor, 78
postdoctoral autonomy and, 79
Fundraising activity
grant writing as, 25
in biotech companies, 86
G
GLP inspections/audits, 54–58
Goals
defining for postdoctoral positions, 73
for collaboration, 111
for considering biotechnology
employment, 83–85
Good Laboratory Practices, 41, 45
definition of, 45–47
documentation of, 47–49
federal regulations pertaining to, 53–54
for biotech companies, 92
inspection processes in, 54–58
inventories in, 50–52
role of standard operating procedures
in, 72
validation protocols for, 49
Good Manufacturing Practices, 45
documentation of, 47–49
federal regulations pertaining to, 53–54
in biotech companies, 92
inspection process in, 54–58
inventories in, 50–52
role of standard operating procedures
in, 72
validation protocols for, 49
Government research laboratories, 74
Graduate students, 7
Grammatical errors, avoiding in grant
applications, 26
Index 161
Index.qxd 7/29/04 4:49 PM Page 161
Grant applications, 3, 17–18
components of, 26
expectations in academia and industry,
121
importance of enthusiasm to, 25
importance of hypothesis driven,
17, 28
papers as basis for, 17
peer review of, 19–20, 27
relevance of manuscript writing to, 25
Grant record, of postdoctoral mentor, 77
Grant writing opportunities, in choice of
postdoctoral mentor, 78
Grants, 15
designing and writing, 25–26
for shared equipment, 121
issues in laboratory closures, 114
relative importance in academia vs.
industry, 136
Grantsmanship, mentoring in, 77
H
Health care benefits
for postdoctoral fellows, 82
in laboratory environments, 107
laboratory closures and, 114
Hiring practices, 128–129, 150
Hiring protocols, 100
Honors, expectations in academia and
industry, 123–124
Human resources personnel, 100
Human Subjects Protection section, in
grant applications, 26, 30–31
Hypotheses, in manuscript format, 22
Hypothesis driven grants, 17, 28
I
Impact factors
in choice of postdoctoral mentor, 77
ISI Web of Knowledge ratings, 108
of specific journals, 23–24
In vitro demonstrations, in product design
process, 40
Independent claims, 36
Indirect costs factor, 121
in grant applications, 27
in laboratory environment, 106
Inducing factors, 61
Industrial technology bubble burst, 86
Industry
common questions for academic
investigators, 137
transitioning from academia to, 135–136
Industry relations, implications of patents
for, 37–38
Information-driven applications, 28
Infrastructure costs, in biotech
companies, 88
Inspection process
for good laboratory/manufacturing
procedures, 54–58
in laboratory closures, 115–116
Installation qualification, 49
Institutional Animal Care and Use
Committee (IACUC), 30
Institutional choices, for postdoctoral
fellowships, 74
Institutional considerations, in
biotechnology companies, 83
Institutional infrastructure expenses, 106
Institutional Review Board, in product
design process, 41
Intellectual infrastructure, in choice of
postdoctoral mentor, 78
Intellectual property, 15, 33
and restrictions on collaboration
opportunities, 80
biotech company policy concerning, 87
defining turf in, 19
Interlibrary loan services, 77
Internal memos, 3
International Organization for
Standardization (ISO), 39
International recruits, 97
Internet job hunting, 128
Internet service costs, 107
Interpersonal relationships
in biotech vs. academia, 90–91
in collaborations, 112
Interpersonal skills, of laboratory job
candidates, 98
Interstate commerce, 42
Interviews
job descriptions as basis for, 129
non-allowed questions in, 98–99
skills in job changes, 136–151
surreptitious, 110
Inventories
in laboratory setup, 93–95
laboratory closure issues, 115–116
162 Index
Index.qxd 7/29/04 4:49 PM Page 162
role in good laboratory/manufacturing
practices, 50–52
Inventors, listing in patent filings,
36–37
Inventorship issues, in collaborations,
111
Investigational new drug phase
in product design process, 41
role of standard operating procedures
in, 72
Investigational Review Board (IRB), 30–31
Investor–founder relationships, 89–90
Investors, 16
Invited talks, patent applications and, 18
ISI Web of Knowledge, 108
J
Job changes
interviewing skills for, 136–141
role of networking in, 136
transitioning between academia and
industry, 135–136
Job descriptions, 106, 128–129
Job stability, in academia vs. biotech, 84
Job title, 130, 138
Joint research activities, 38
Journals
impact factor of, 23–24
page charges by, 23
L
Labeling information, 41
in Biologics License Application, 43
Laboratory administration
budget preparation in, 104–105
direct costs in, 105–106
establishing a laboratory culture, 102
hiring strategies in, 100
indirect costs in, 106
meritocracy structures, 131
micromanagement issues in, 103–104
performance review process in, 100–102
personnel recruitment in, 97–100
publication expectations in, 107–108
role of guest seminars, 109–110
role of off site meetings in, 108–109
role of sabbaticals in, 109
salaries and fringe benefits in,
106–107
service costs in, 107
shared responsibilities in, 102–103
support staff in, 102–103
Laboratory closures, 113–115
equipment issues in, 116
grant and contract issues in, 114
key considerations for, 114
public disclosure of, 114
Laboratory culture, 102
Laboratory notebooks
importance of, 48–49
role in good laboratory/manufacturing
practices, 52–53
Laboratory setup
equipment and materials in, 95
maintaining inventories in, 93–95
methods, protocols, and standard
operating procedures in, 96
organizing, 92
Land grant universities, 74
USDA support for, 75
Landmark papers, reviewing in grant
applications, 28
Language choice, 3
Layoffs, in biotech vs. academia, 85
Leadership skills
in personal development, 148–152
of job candidates, 101
Least publishable unit, 22
Legal department, in biotech subculture,
13
Legal fees, in patent applications, 35
Legal language, in patent applications,
35–36
Libraries, importance in postdoctoral
fellowship selection, 77
Licensing, of patented information/
products, 35–36, 37
Liquid nitrogen, inventories of, 94
Listening skills, 6
Lists, organizing for communications, 7–8
Litigious issues, in collaboration, 111
Local recruits, 97
Log sheets, 47
Long-range planning, 7
M
Machines, patenting, 35
Maintenance fees, in patent applications,
37
Index 163
Index.qxd 7/29/04 4:49 PM Page 163
Management techniques, 9
Management training, expectations in
academia and industry, 125
Manuals, in laboratory setup, 95
Manufactured articles, patenting, 35
Manufacturing
as biotech subculture, 12
culture of, 45
Manuscripts
as basis for grant applications, 17
contents of, 21–24, 22
designing, 21
for publication, 3
importance to grant writing tasks, 25
peer reviews of, 19–20
productivity expectations for
postdoctoral fellows, 80
relative importance in academia vs.
industry, 136
Marketing department, in biotech
subculture, 12–13
Matching funds, 121
Material transfer agreements (MTAs), 38
Materials
documenting in experimental protocols,
60
listing in experimental protocols, 60
Materials section
for experimental methods, 68–69
in grant applications, 29
in manuscript format, 22
Medical departments
as biotech subculture, 12
financial resources in universities, 138
in public universities, 74
Meetings
appropriate frequency of, 8–9
frequency of mentor-fellow, 81
Mentoring, 129–131
Mentors
choice of postdoctoral, 75–78
in postdoctoral positions vs.
biotechnology employment, 83
Meritocracies, 131
Methods
in laboratory setup, 96
patenting, 35
Methods section
in grant applications, 29
in manuscript format, 22
Metrics, defining in grant applications,
29
Micromanagement
as personal development issue, 147–148
in laboratory environment, 103–104
Milestones
importance in grant applications, 18
importance of recording, 8
Morale, communications and, 9
Moving expense reimbursements
for postdoctoral fellows, 82
in academia vs. industry, 139, 140
in laboratory closures, 114
N
National Institutes for Standards and
Technology (NIST), target audience
for grants to, 27
National Institutes of Health, 121, 153
grant applications to, 6, 17
preliminary data in grant applications
to, 29
support for academia by, 84
support for medical centers, 75
target audience for grants to, 27
National Library of Medicine web site, 77
National recruits, 97
National Science Foundation (NSF), 121
support for academia by, 84
Nature, 80
Nepotism regulations, 129
Networking, role in changing jobs, 136
New matter, in patent applications, 37
Nonclinical Pharmacology and Toxicology
section, in Biologics License
Application, 43
Nonobviousness, in patent applications,
34–35
Nonprofit research foundations, 74, 75
revenue-generating endowments at, 75
Nonprovisional patent applications, 36–37
Nonverbal cues, 1–2
Notebooks
documenting, 52
importance of documentation in, 48
in good laboratory/manufacturing
practices, 52–53
inventories of, 94
Notice of allowance, in patent
applications, 37
Novelty, in patent applications, 34
Numbering systems documents, 48
164 Index
Index.qxd 7/29/04 4:49 PM Page 164
O
Objectives
for experimental methods, 68
in communications, 8
in experimental protocols, 60
in experimental reports, 64
Off site meetings, 108–109
Office actions, in patent applications, 37
Oligonucleotides, documenting, 52
One-on-one communications, 3
Open-door policy, vs. culture of secrecy,
87
Operating procedures, 3
Operational criteria, 50
Operational qualification, 49–50
Oral communication skills, 2–3
Oral presentations
at off site meetings, 109
keeping updated records of,
123–124
patents and, 18
Ordering responsibilities, in laboratory
environment, 105
Organization and personnel, in GLP
inspections/audits, 54–55
Organizational hierarchy, in biotech vs.
academia, 89
Outcome criteria, in experimental
protocols, 61
Outlines
for public speaking engagements, 5
in grant applications, 28
Outside activities, 144–145
P
Package insert, in Biologics License
Application, 43
Page charges, from journals, 23
Papers, importance in academia and
biotechnology, 15–17
Passive voice, avoiding in written
communications, 5
Past tense, avoiding in written
communications, 5
Patent alternatives, 35
Patent applications, 3, 18–19
components of, 36
designing and writing, 33
determining merits of, 34–35
implications of notebooks in, 53
Patent assignee, 35, 36
Patent examiners, 37
Patent Information section, in Biologics
License Application, 43
Patent infringements, 35
Patentability, 34–35
Patents
expectations in academia and industry,
124–125
inventorship rights in collaborations,
111
relative importance in academia and
biotechnology, 15
Peer reviewers
expectations in academia and industry,
121–122
for grant applications, 27
Peer-reviewed manuscripts, 3, 19–20
and experimental design of grant
applications, 29
importance in academia and
biotechnology, 15–17
Percentage of profits, from patented
information/products, 35
Performance qualification, 49, 50
Performance review process,
100–102
Personal appearance, in biotech vs.
academia, 89
Personal development issues
communication skills, 154
fostering creativity, 154–155
leadership training, 148–152
micromanaging, 147–148
project management and team building,
152–153
teaching responsibilities, 153–154
Personal goals, defining for biotechnology
employment, 83–85
Personal life issues, 143
child care, 143–144
family and friends, 144
outside activities, 144–145
Personality matches, in postdoctoral
fellowships, 76
Personnel management skills, 127
hiring skills, 128–129
mentoring, 129–130
promoting practices, 131–132
recruiting skills, 127–128
terminating employees, 133–134
Index 165
Index.qxd 7/29/04 4:49 PM Page 165